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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Peripheral Mechanical Thrombectomy With Aspiration
510(k) Number K213402
Device Name Triever24, Triever20
Applicant
Inari Medical
9 Parker, Suite 100
Irvine,  CA  92618
Applicant Contact Kit Cariquitan
Correspondent
Inari Medical
9 Parker, Suite 100
Irvine,  CA  92618
Correspondent Contact Kit Cariquitan
Regulation Number870.5150
Classification Product Code
QEW  
Subsequent Product Code
KRA  
Date Received10/18/2021
Decision Date 05/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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